Medical Director, Structural Heart

Role Summary

Medical Director, Structural Heart – The Director will provide medical affairs leadership and clinical expertise to support the development of medical devices for structural heart diseases. This role shapes the medical direction of the structural heart business, ensures regulatory compliance, and collaborates across R&D, Clinical Research, and commercial teams to drive evidence generation, training, and product adoption.

Responsibilities

• Lead and support all clinical studies for regulatory purposes and physician-initiated collaborations, including case support plans, training, data analysis, and publication support.
• Develop and execute product and procedural evidence generation and dissemination strategies for company-sponsored and investigator-initiated research.
• Collaborate with preclinical and clinical evidence-generation teams to develop global strategies for evidence generation to support regulatory approval, HTA, customer access, and post-marketing support.
• Provide scientific oversight for clinical trial concept, design, analysis, and reporting; develop materials for study execution (investigator brochures, training materials, etc.).
• Work with Medical Safety to review, trend, and escalate adverse events from clinical studies as needed.
• Provide input on study results and prepare reports for regulatory submissions and publications to meet evidence requirements.
• Ensure medical content for internal product documentation and regulatory submissions; safeguard patient safety.
• Approve Design History Files, Technical Guides, and CERs; review educational, promotional, and reporting materials for internal stakeholders.
• Strategize and prioritize publication proposals in collaboration with Clinical Science.

Cross Function Collaborations

• Collaborate with R&D, Clinical Research, Business Development, Regulatory Affairs, Quality & Compliance, Health Economics & Market Access, and Professional Medical Education to influence regulatory and commercial strategy, clinical studies, safety assessments, and product launch/training.
• Participate in governance forums (Business Unit leadership, cross-functional product core teams, EGS teams, portfolio/strategy management, Safety and Quality Review Boards).
• Support commercial launch by activating sites, providing physician training, and collecting feedback on product performance and improvements.
• Provide medical and scientific insights to Marketing, R&D, Communications, Legal, QA/Risk, Product Safety, and Commercial teams to guide strategic direction.

External Engagements

• Engage Key Opinion Leaders, professional societies, payers, and providers to understand care trends and gather insights for product innovation.
• Develop relationships with academic leaders researching structural heart interventions; collaborate with other functions interacting with customers/physicians.
• Travel up to 35% as needed.

Program Oversight and Team Development

• Align strategy, budget, and resource allocation with cross-functional partners.
• Recruit, mentor, and develop the Structural Heart Interventions Medical Affairs team.
• Ensure compliance with health, safety, and environmental practices and regulatory requirements.

Qualifications

• A degree in medicine (MD, DO, etc.) with training in Interventional Cardiology is required.
• Minimum 10 years of relevant experience in Structural Heart Interventions; experience in product development for Structural Heart Interventions is highly desired.
• Cardiovascular/structural heart knowledge strongly preferred; significant experience with clinical research required.
• Strong leadership, relationship-building, and people-management skills; ability to collaborate in a matrix environment.
• Experience leading medical/clinical teams in regulated biomedical or medical device settings; risk evaluation and mitigation experience preferred.
• Excellent communication and negotiation skills; willingness to travel ~35% domestically and internationally.

Education

• A degree in medicine (MD, DO, etc.) with training in Interventional Cardiology is required.